Nighttime Cold and Flu

Description

This formulation contains Acetaminophen 650 mg, Dextromethorphan HBr 30 mg, and Doxylamine succinate 12.5 mg. The product also includes 10% alcohol as an inactive ingredient. It is manufactured by PL Developments, located at 11865 S. Alameda St, Lynwood, CA 90262. This product is not manufactured or distributed by The Procter & Gamble Company; Vicks® and NyQuil® are registered trademarks of The Procter & Gamble Company. The product features a tamper-evident design; do not use if the printed safety seal around the bottle or under the cap is broken or missing.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, sore throat, fever, runny nose, sneezing, and cough due to minor throat and bronchial irritation.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage guidelines to avoid potential overdose. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 30 mL administered every 6 hours as needed. It is imperative that the dosing cup provided with the product is used for measurement; no other dosing devices should be utilized to ensure accurate dosing. The dosing cup should be kept with the product at all times.

For children under 12 years of age, the product is not recommended for use.

When utilizing other Day Time or Night Time products, healthcare professionals should advise patients to carefully read each label to confirm appropriate dosing and avoid exceeding the recommended limits.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for 2 weeks following the discontinuation of an MAOI. The combination may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised.

Concurrent use with any other drug containing acetaminophen, whether prescription or non-prescription, is also contraindicated due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is imperative to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician promptly.

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems or chronic cough (such as those related to smoking, asthma, chronic bronchitis, or emphysema), or difficulty urinating due to an enlarged prostate gland. Additionally, patients should be cautioned to seek advice from a doctor or pharmacist if they are taking sedatives, tranquilizers, or the anticoagulant warfarin.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, even if no symptoms are apparent.

Discontinuation of Use Patients should stop taking this product and consult a healthcare provider if any of the following occur: pain or cough worsens or persists beyond seven days; new symptoms develop; fever worsens or lasts more than three days; redness or swelling is observed; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants should also be cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is advisable to consult a healthcare professional promptly.

While using this product, excitability may occur, particularly in children, and marked drowsiness is a common adverse reaction. Patients are advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Caution is recommended when driving or operating machinery.

Patients should discontinue use and consult a doctor if pain or cough worsens or lasts longer than seven days, if new symptoms arise, if fever worsens or persists for more than three days, or if redness or swelling is observed. Additionally, if a cough recurs or is accompanied by a rash or headache that lasts, these may indicate a serious condition requiring medical evaluation.

An overdose warning is also pertinent; taking more than the recommended dose can lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

The concomitant use of this medication with monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication while currently taking a prescription MAOI or within 2 weeks of discontinuing an MAOI treatment.

Caution is advised when this medication is used alongside sedatives or tranquilizers. Patients are encouraged to consult with a healthcare professional, such as a doctor or pharmacist, prior to use if they are currently taking these types of medications.

Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare professional before using this medication, as potential interactions may necessitate monitoring or dosage adjustments.

The use of alcohol, sedatives, and tranquilizers in conjunction with this medication may enhance drowsiness. Therefore, patients should be advised to exercise caution when engaging in activities that require alertness.

Packaging & NDC

Below are the non-prescription pack sizes of Nighttime Cold and Flu (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For patients aged 12 years and older, the recommended dosage is 30 mL every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children, and marked drowsiness is also a potential side effect. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the side effects of the active ingredients in this product, particularly the sedative effects associated with doxylamine succinate. While there are no specific dosage adjustments or safety concerns outlined for geriatric patients, caution is advised when administering this product to individuals aged 65 and older.

The product is intended for use in adults and children aged 12 years and older, suggesting that it may not be suitable for very elderly patients without prior consultation with a healthcare provider. It is recommended that elderly patients, especially those with underlying health conditions, seek medical advice before use to ensure safety and appropriateness of treatment. Monitoring for adverse effects is prudent in this population due to their potential increased sensitivity.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulties urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is critical that patients do not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three drinks per day while using this product.

Before using this product, patients with liver disease are advised to consult a healthcare professional. In the event of an overdose, which is defined as taking more than the recommended dose, patients may be at increased risk for liver damage. Immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) should be made without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are present.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is crucial for healthcare professionals to recognize the seriousness of an overdose and the potential for severe health consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is essential, as quick medical attention can be critical for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Monitoring and management of the patient should be initiated as soon as possible to mitigate the risks associated with liver damage and to ensure appropriate care is provided.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use due to potential teratogenic effects.

Excitability may occur, particularly in children, alongside marked drowsiness. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

No specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

Postmarketing experience has identified several important safety considerations associated with the use of acetaminophen. Reports indicate that acetaminophen may cause severe skin reactions, with symptoms including skin reddening, blisters, and rash. Additionally, excitability has been noted, particularly in pediatric populations. Users may also experience marked drowsiness, which can be exacerbated by the concurrent use of alcohol, sedatives, and tranquilizers.

Healthcare professionals are advised to instruct patients to discontinue use and seek medical advice if pain or cough worsens or persists beyond 7 days, if new symptoms arise, if fever intensifies or lasts more than 3 days, if redness or swelling occurs, or if cough recurs alongside a rash or headache that lasts.

Furthermore, there is a significant risk of liver damage associated with acetaminophen overdose. It is crucial for individuals to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) if an overdose is suspected, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are present.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease should be cautioned against using this product. They should be informed to wait at least two weeks after stopping an MAOI before using this medication. If patients are uncertain whether their prescription contains an MAOI, they should consult their doctor or pharmacist.

It is important to instruct patients not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or non-prescription. Patients should be encouraged to ask their healthcare provider if they are unsure about the presence of acetaminophen in their other medications.

Patients should be advised to discontinue use and consult a doctor if their pain or cough worsens or persists for more than seven days, if new symptoms arise, if fever worsens or lasts more than three days, or if there is any redness or swelling. Additionally, they should seek medical advice if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients may experience excitability, particularly in children, and marked drowsiness. They should be cautioned to avoid alcoholic beverages, as well as to exercise caution when driving or operating machinery. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Patients with liver disease, glaucoma, or a cough accompanied by excessive phlegm should be advised to consult their doctor before using this product. Those with breathing problems or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Furthermore, patients experiencing difficulty urinating due to an enlarged prostate gland, as well as those taking sedatives, tranquilizers, or the blood-thinning medication warfarin, should consult their healthcare provider or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper storage conditions must be maintained to ensure the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. Additionally, it is important to keep the medication out of reach of children to ensure safety. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Nighttime Cold and Flu, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)